IPrEx
Trial question
What is the role of preexposure chemoprophylaxis in HIV-seronegative men or transgender women who have sex with men?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
1.0% female
99.0% male
N = 2499
2499 patients (29 female, 2470 male).
Inclusion criteria: HIV-seronegative men or transgender women who have sex with men.
Key exclusion criteria: elevated hepatic aminotransferase levels, hyperbilirubinemia, and renal insufficiency, previous receipt of antiretroviral therapy, or acute hepatitis B infection, diabetes, tuberculosis, and cancer.
Interventions
N=1251 oral antiretroviral drugs (emtricitabine and tenofovir disoproxil fumarate once daily plus HIV testing, risk-reduction counseling, condoms, and management of STIs).
N=1248 placebo (matching placebo plus HIV testing, risk-reduction counseling, condoms, and management of STIs).
Primary outcome
Emergence of human immunodeficiency virus infection in modified intention-to-treat population
36
64
64.0
48.0
32.0
16.0
0.0
Oral antiretroviral
drugs
Placebo
Significant
increase ▲
Significant increase in emergence of HIV infection in the modified intention-to-treat population (36 vs. 64; RR 44, 95% CI 15 to 63).
Secondary outcomes
Significant decrease in pill use on ≥ 50% days (23 vs. 47; HR 0.5, 95% CI 0.3 to 0.82).
Safety outcomes
No significant difference in serious adverse events (p=0.57).
Significant difference in nausea during the first week more frequently reported in the FTC-TDF group than the placebo (p < 0.001).
Conclusion
In HIV-seronegative men or transgender women who have sex with men, oral antiretroviral drugs were superior to placebo with respect to emergence of HIV infection in the modified intention-to-treat population.
Reference
Grant RM, Lama JR, Anderson PL et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99.
Open reference URL